[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.3030]

[Page 495-496]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 888_ORTHOPEDIC DEVICES--Table of Contents
 
                      Subpart D_Prosthetic Devices
 
Sec. 888.3030  Single/multiple component metallic bone fixation
appliances and accessories.

    (a) Identification. Single/multiple component metallic bone fixation 
appliances and accessories are devices intended to be implanted 
consisting of one or more metallic components and their metallic 
fasteners. The devices contain a plate, a nail/plate combination, or a 
blade/plate combination that

[[Page 496]]

are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, 
and titanium, that are intended to be held in position with fasteners, 
such as screws and nails, or bolts, nuts, and washers. These devices are 
used for fixation of fractures of the proximal or distal end of long 
bones, such as intracapsular, intertrochanteric, intercervical, 
supracondylar, or condylar fractures of the femur; for fusion of a 
joint; or for surgical procedures that involve cutting a bone. The 
devices may be implanted or attached through the skin so that a pulling 
force (traction) may be applied to the skeletal system.
    (b) Classification. Class II.